FDA Requires Device Manufacturers to Include Information on Pediatric Populations

FDA Requires Device Manufacturers to Include Information
on Pediatric Populations

New Rule Applies Requirements in 2007 FDA Amendments
Act

The U.S. Food and Drug Administration announced today that will
begin implementing a requirement that device manufacturers provide
readily available information in certain premarket applications on
pediatric patients who suffer from the disease or condition that
the device is intended to treat, diagnose, or cure, even if the
device is intended for adult use.

Very few devices are developed or assessed specifically for use
in pediatric patients, those 21 or younger at the time of treatment
or diagnosis. This effort will provide a better understanding of
which devices developed for use in adults should be assessed or
modified for use in pediatric populations. The requirements,
contained in the Food and Drug Administration Amendments Act of
2007, will also improve the agency's ability to track the number of
approved devices for which there is a pediatric subpopulation who
could benefit and the number of approved devices labeled for use in
pediatric patients.

"This requirement allows the agency to collect information that
will help us better assess public health needs for medical devices
that can be used for pediatric populations," said Jeffrey Shuren,
M.D., director of the FDA's Center for Devices and Radiological
Health.

Under the 2007 legislation, manufacturers must provide certain
pediatric information, if readily available, with each premarket
approval application or supplement, humanitarian device exemption
request, or product development protocol. Manufacturers now must
include a description of any pediatric subpopulations that suffer
from the disease or condition that the device is intended to treat,
diagnose, or cure. Manufacturers also must include the number of
affected pediatric patients.

If the manufacturer does not submit such information, the FDA
may not approve the application until the required information is
provided.